LSC have a great contract opportunity for a Quality Assurance Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 8+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Serve as the QA lead / QA representative for Technology Transfer and New Product Introduction (NPI) project teams, providing quality oversight throughout the product transfer lifecycle.
- Review and approve technology transfer documentation, including transfer plans, process validation / PPQ protocols and reports, risk assessments and supporting technical documentation.
- Support introduction change controls, deviations and CAPAs, ensuring product/process impact, regulatory impact, validation requirements and associated risks are appropriately assessed and controlled.
- Provide QA oversight for PPQ and operational readiness activities, including batch records, recipes, BOMs, equipment qualification, media fills, environmental monitoring and validation documentation.
- Partner with Process Development, Engineering, Manufacturing, Validation, QC and Regulatory teams to support compliant transfer execution, regulatory filing and commercial readiness.
- Provide QA input into quality risk assessments and issues arising during engineering runs, PPQ batches and transfer execution, ensuring compliant and risk-based decision-making.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's or Master's degree in Science, Engineering, Biotechnology or a related discipline, with a minimum of 8 years' experience in pharmaceutical or biotechnology manufacturing.
- Strong GMP QA experience with direct involvement in Technology Transfer, NPI, process validation and/or PPQ, including change control, deviations, CAPAs and quality risk management.
- Experience in sterile drug product, aseptic manufacturing, vial or syringe filling is strongly preferred; transferable Tech Transfer QA experience from biologics drug substance or other GMP manufacturing environments may also be considered.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Jenny Murphy on 021 4777329 if you have any more questions about this role!
